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Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05006001
Enrollment
2000
Registered
2021-08-16
Start date
2012-01-01
Completion date
2024-12-31
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colchicine Adverse Reaction, Gout, Nonsteroidals (NSAIDs)Toxicity, Renal Impairment

Keywords

Acute kidney injury, Renal impairment, Nonsteroidal antiinflammatory drug, Drug-drug interaction

Brief summary

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Detailed description

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent. Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Interventions

DRUGColchicine and NSAID

Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Sponsors

En Chu Kong Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Clinical diagnosis of a gout diagnosis * Initially receiving at least one anti-gout drug

Exclusion criteria

* \<1 year of continuous health insurance enrollment * Colchicine and NSAID use before the cohort entry date * Patients with hemodialysis or peritoneal dialysis before the cohort entry date * Patients with acute kidney injury before the cohort entry date

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injuryThrough study completion, an average of 1 yearNumber of participants with a diagnosis of acute kidney injury

Secondary

MeasureTime frameDescription
All cause mortalityThrough study completion, an average of 1 yearNumber of participants with a death record
Hemodialysis or peritoneal dialysisThrough study completion, an average of 1 yearNumber of participants with a dialysis record

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026